Randomised clinical trial: a 1-week, double-blind, placebo-controlled study of pancreatin 25 000 Ph. Eur. minimicrospheres (Creon 25000 MMS) for pancreatic exocrine insufficiency after pancreatic surgery, with a 1-year open-label extension.

"The authors thank Dr Andre L. Mihaljevic for his contribution. Declaration of personal interests : Jakob Izbicki, Lajos Varga-Szabó, László Czakó, János Fiók, Cosimo Sperti, Raffaele Pezzilli, Galina Vasileva, Ákos Pap, Márta Varga, Helmut Friess have no relevant conflicts of interest to disclose. Christoph M. Seiler has had travel/accommodation expenses covered or reimbursed by Ethicon, Inc. Markus M. Lerch has served as a speaker for Altana, Falk, Roche, Axcan, Solvay, Abbott, Menarini, Lilly and Novartis, as a consultant for Alpina, Roche, Lilly, AstraZeneca, Abbott and Menarini, has received research funding from the Deutsche Forschungsgemeinschaft, the Deutsche Krebshilfe, the European Union and the German Federal Government (BMBF), and holds patents on several genes and metabolites found to be potential biomarkers for pancreatic diseases. Declaration of funding interests : This study was funded in full by Abbott. Abbott was involved in the design and conduct of the study and provided logistical support during the trial. Abbott worked with DATAMAP GmbH to prepare the statistical analysis plan, and the data analysis was undertaken by DATAMAP GmbH, funded by Abbott. Medical writing support was provided by Helen Varley, PhD, of Envision Scientific Solutions, Horsham, UK and funded by Abbott."

"Declaration of funding interests: This study was funded in full by Abbott. Abbott was involved in the design and conduct of the study and provided logistical support during the trial. Abbott worked with DATAMAP GmbH to prepare the statistical analysis plan, and the data analysis was undertaken by DATAMAP GmbH, funded by Abbott. Medical writing support was provided by Helen Varley, PhD, of Envision Scientific Solutions, Horsham, UK and funded by Abbott."

"This was a 1-week, double-blind, randomised, placebo-controlled, parallel-group study with a long-term OLE. The study was registered at EudraCT: number 2005-004854-29. The study was carried out at centres in Bulgaria (n = 2), Germany (n = 4), Hungary (n = 8) and Italy (n = 3) between April 2008 and July 2011, and 15 of these 17 centres contributed patients. It was conducted in accordance with the EU Clinical Trial Directive 2001/20/EC, the International Conference on Harmonization guideline for Good Clinical Practice 1996 and the principles of the Declaration of Helsinki. The study protocol and informed consent form were approved by Ethics Committees complying with local regulatory requirements. All subjects provided voluntary written informed consent before any study-related procedures were carried out."